DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
References to the instant application’s as-filed specification has been made using USPGPub. version of the specification in this Office action.
Status of Claims
Claims 1-20 are currently pending and under consideration.
Claim Objections
Claim 12 is objected to because of the following informalities: The limitation of “to evaluate the therapeutic outcome” in lines 1-2 should be corrected to --the therapeutic outcome evaluation step--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163(II)(A)(3)(a)(ii) states the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
The claims 1 and 13 and their dependent claims are drawn broadly to electrostimulation of generic “neural targets” and determination of stimulation settings for such targets based on sensed ERs to “produce a desired therapeutic outcome.” As-filed specification in [0005] discloses the following:
DBS may improve motor symptoms in some patients with advanced Parkinson's Disease (PD), and other motor and non-motor disorders. Stimulation leads/electrodes for PD treatment are commonly implanted in subthalamic nucleus (STN) or globus pallidus internus (GPi), although other neural targets, such as pedunculopontine nucleus (PPN) and posterior subthalamic area (PSA), and others, have been shown as effective targets for Parkinsonian tremor control and control of other Parkinson's symptoms in patients. However, optimal target(s) of DBS to manage PD and other movement and non-movement disorders may vary across patients, and there is no best “universal” DBS target. A DBS system capable of providing versatile and flexible stimulation at multiple neural targets is desired to accommodate the needs of patients with different conditions.
As-filed specification discloses two particular neural targets, subthalamic nucleus (STN) or globus pallidus internus (GPi) (see [0011] [0024], [0050], [0084], [0087], [0090], and [0096]) for the purpose of treating Parkinson's Disease (PD). While other neural targets and conditions are nominally discussed ([0003]), the as-filed specification does not provide any details of specific neural targets and associated conditions that would be necessary to determine and produced a desired therapeutic outcome other than one exemplary embodiment for PD, where the neural targets are STN and GPi. As such, the as-filed specification does clearly demonstrate possession of the full breadth of the claimed subject matter across the recited generic neural targets and therapeutic settings and outcome.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “desired therapeutic outcome” in claims 1, 5, 11, 13, and 16 is a relative term which renders the claim indefinite. The term “desired therapeutic outcome” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear whether “desired therapeutic outcome” is indicative of a complete or partial recovery, thus applicant is recommended to more explicitly define the bounds of a “desired therapeutic outcome”. Claims 2-4, 6-10, 12, 14, 15, and 17-20 are dependent claims of either claim 1 or 13 and therefore indefinite for the same reasons set forth for claims 1 and 13 above.
The terms “substantially” and “specific” in claims 2 and 14 are relative terms which render the claim indefinite. The term “substantially” and “specific” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what degree of timing would read on delivery of electrostimulation simultaneously or sequentially due to the use of relative terms “substantially” and “specific.”
The term “desired ER spatial distribution” in claims 12 and 20 is a relative term which renders the claim indefinite. The term “desired ER spatial distribution” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to whether matching/control is based on the first-target ER, second-target ER, or a compound ER.
The term “desired modulation” in claims 19 is a relative term which renders the claim indefinite. The term “desired modulation” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as the what type of modulation (e.g, defined by target ER magnitude, threshold, template, or stored acceptance criterion) would be considered “desired” modulation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6-7, 9-11, 13-14, 17, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Linde et. al, (US 20210121697 A1, published 04/29/2021, hereinafter known as Linde).
Regarding claim 1, Linde discloses a neuromodulation system (“system configured to deliver electrical stimulation therapy” [0054]), comprising:
at least one lead including a plurality of electrodes (“therapy system includes…a lead, electrodes” [0054]);
an electrostimulator configured to provide electrostimulation to neural targets of a patient via one or more of the plurality of electrodes of the at least one lead (“therapy system configured to deliver electrical stimulation therapy to brain…to deliver electrical stimulation to brain of patient via electrodes” [0054-0055]);
a sensing circuit configured to sense an evoked response (ER) to the electrostimulation (“electrical signals that may be sensed by electrical sensing module include… evoked response signals” [0113]); and
a controller circuit operably connected to the electrostimulator and the sensing circuit (“programmer may be used by a clinician to control the delivery of electrical stimulation”, element 22, as seen in Fig. 1 [0070]), the controller circuit configured to:
in response to the electrostimulation delivered to a first neural target in accordance with a first stimulation setting, collect an ER sensed via the sensing circuit from a first sensing electrode positioned at a first sensing location (“processor may cause stimulation generator to deliver electrical stimulation to a first target tissue site via a first subset of electrodes (e.g., electrodes located on lead segment) in a first stimulation mode…electrical signals that may be sensed by electrical sensing module include… evoked response signals” [0092] & [0113]);
based at least in part on the sensed ER to the electrostimulation at the first neural target, determine or adjust a second stimulation setting for stimulating a second neural target of the patient different from the first neural target (“if LD2 detects a biomarker that is below a first threshold and a second threshold, then IMD may decrease a second therapy or turn the second therapy off” [0169]);
generate a control signal to the electrostimulator to provide electrostimulation at the second neural target in accordance with the second stimulation setting to modulate the sensed ER to the electrostimulation at the first neural target (“delivering stimulation to a second target area different than the first target area and/or according to a second set of parameter settings different than the first set of parameter settings” [0052]) and to produce a desired therapeutic outcome in the patient (“electrical stimulation delivered by each of the subsets of electrodes may be delivered according to a different one of a plurality of therapy programs” [0092] and “If the trial stimulator indicates DBS system 100 provides effective treatment to patient 112, the clinician may implant a chronic stimulator within patient 112 for relatively long-term treatment” [0109]); and
collect an ER to the electrostimulation at the second neural target sensed via the sensing circuit from a second sensing electrode positioned at a second sensing location (“deliver electrical stimulation to a second target area via a second subset of electrodes (e.g., electrodes located on lead segment) in a second stimulation mode… electrical signals that may be sensed by electrical sensing module include… evoked response signals” [0092] & [0113]).
Regarding claims 2 and 14, Linde discloses the controller circuit is configured to control the electrostimulator to deliver respective electrostimulations to the first and the second neural targets substantially simultaneously, or sequentially with a specific time offset in accordance with respective the first and the second stimulating settings (“electrical stimulation that is delivered via each of the subsets of electrodes may be controlled independently and may be controlled and delivered either simultaneously or alternately in time… stimulation mode and stimulation mode may operate concurrently” [0092] & [0188]).
Regarding claim 6, Linde discloses the electrostimulator is electrically coupled to a multielectrode lead (“example lead includes lead segments…lead segments each include a set of electrodes that form a part of electrodes…lead segments may each carry four, eight, or sixteen electrodes” [0060]), the electrostimulator configured to provide electrostimulation to the first neural target via a first electrode on the multielectrode lead, and to provide electrostimulation to the second neural target via a second electrode on the same multielectrode lead (“IMD may be configured to deliver stimulation in a bipolar mode (e.g., by an anode and cathode on a lead)” [0064]).
Regarding claims 7 and 17, Linde discloses the at least one lead includes distinct first and second leads each including one or more electrodes (leads 28 and 30 as shown in Fig. 1, “lead segments may each carry four, eight, or sixteen electrodes” [0060]), wherein the electrostimulator is configured to provide electrostimulation to the first neural target via a first electrode on the first lead, and to provide electrostimulation to the second neural target via a second electrode on the second lead (“IMD may be configured to deliver stimulation in a bipolar mode (e.g., by an anode and cathode on a lead)” [0064]).
Regarding claim 9, Linde discloses the controller circuit is configured to determine or adjust the second stimulation setting such that the electrostimulation at the second neural target in accordance with the second stimulation setting reduces the ER to the electrostimulation at the first neural target (“stimulation parameters may be increased or decreased via entry actions…if LD2 detects a biomarker that is below a first threshold and a second threshold, then IMD may decrease a second therapy or turn the second therapy off” [0085] & [0169]).
Regarding claim 10, Linde discloses the controller circuit is configured to determine or adjust the second stimulation setting such that the electrostimulation at the second neural target in accordance with the second stimulation setting enhances the ER to the electrostimulation at the first neural target (“stimulation parameters may be increased or decreased via entry actions…if LD1 detects a biomarker that is above a first threshold and a second threshold, then IMD may increase the first therapy or turn the first therapy on” [0085] & [0169]).
Regarding claim 11, Linde discloses to determine or adjust the second stimulation setting based at least in part on the sensed ER to the electrostimulation at the first neural target (“if LD2 detects a biomarker that is below a first threshold and a second threshold, then IMD may decrease a second therapy or turn the second therapy off” [0169]), the controller circuit is configured to:
evaluate a therapeutic outcome using the sensed ER to the electrostimulation at the first neural target (“therapy decisions generated by the state machine implemented by IMD may include…determining whether to increase, decrease, or keep constant one or more stimulation parameters used for delivering electrical stimulation therapy” [0077]); and
based on the evaluation of the therapeutic outcome, determine or adjust the second stimulation setting including one or more stimulation parameters or one or more electrodes selected from the plurality of electrodes of the at least one lead for electrostimulation (“stimulation parameters that may be adjusted may include, e.g., an amplitude of the stimulation, a pulse width of the stimulation, a frequency of the stimulation, and a target area for the stimulation” [0077]).
Regarding claim 13, Linde discloses a method of providing neurostimulation to neural targets of a patient via a neuromodulation system that comprises an electrostimulator and at least one lead coupled thereto (“therapy system includes…a lead, electrodes” [0054]), the method comprising:
delivering electrostimulation to a first neural target in accordance with a first stimulation setting using the electrostimulator (“processor may cause stimulation generator to deliver electrical stimulation to a first target tissue site” [0092]);
sensing an evoked responses (ER) to the electrostimulation at the first neural target via a first sensing electrode positioned at a first sensing location (“electrical signals that may be sensed by electrical sensing module include… evoked response signals” [0113]);
via a controller circuit, determining or adjusting a second stimulation setting for stimulating a second neural target of the patient different from the first neural target based at least in part on the sensed ER to the electrostimulation at the first neural target (“if LD2 detects a biomarker that is below a first threshold and a second threshold, then IMD may decrease a second therapy or turn the second therapy off” [0169]);
delivering electrostimulation to the second neural target in accordance with the second stimulation setting to modulate the sensed ER to the electrostimulation at the first neural target (“delivering stimulation to a second target area different than the first target area and/or according to a second set of parameter settings different than the first set of parameter settings” [0052]), and to produce a desired therapeutic outcome in the patient (“electrical stimulation delivered by each of the subsets of electrodes may be delivered according to a different one of a plurality of therapy programs” [0092] and “If the trial stimulator indicates DBS system 100 provides effective treatment to patient 112, the clinician may implant a chronic stimulator within patient 112 for relatively long-term treatment” [0109]);); and
sensing an ER to the electrostimulation at the second neural target via a second sensing electrode positioned at a second sensing location (“deliver electrical stimulation to a second target area via a second subset of electrodes (e.g., electrodes located on lead segment) in a second stimulation mode… electrical signals that may be sensed by electrical sensing module include… evoked response signals” [0092] & [0113]).
Regarding claim 19, Linde discloses the second stimulation setting is determined or adjusted such that the electrostimulation at the second neural target in accordance with the second stimulation setting produces a desired modulation of the ER to the electrostimulation at the first neural target, the desired modulation including reducing the ER to the electrostimulation at the first neural target, or enhancing the ER to the electrostimulation at the first neural target (“stimulation parameters may be increased or decreased via entry actions…if LD1 detects a biomarker that is above a first threshold and a second threshold, then IMD may increase the first therapy or turn the first therapy on…if LD2 detects a biomarker that is below a first threshold and a second threshold, then IMD may decrease a second therapy or turn the second therapy off” [0085] & [0169]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3, 4, 5, 8, 15-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Linde in view of Hageman et. al, (US 20230166111 A1, published 06/01/2023, hereinafter known as Hageman).
Regarding claims 3 and 15, Linde discloses the first neural target of electrostimulation is a subthalamic nucleus (STN) target in a hemisphere of a brain (“target area may be one of a subthalamic nucleus” [0210]), and the second neural target of electrostimulation is a globus pallidus internus (GPi) target (“target area may be one of an internal globus pallidus” [0210]).
Linde does not disclose that the GPi target is in the same hemisphere of the brain.
However, Hageman teaches a system that includes memory and processing circuitry coupled to the memory and configured to control stimulation generation circuitry to deliver a plurality of electrical stimulation signals via one or more electrodes (Abstract). Leads and may be implanted within the same hemisphere or IMD may be coupled to a single lead implanted in a single hemisphere in order to deliver electrical stimulation to one or more regions of brain, which may be selected based on the patient condition or disorder controlled by therapy system [0094].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the targeting of the same hemisphere of the brain of Hageman with the neuromodulation system of Linde because delivering electrostimulation to the STN and GPi in the same hemisphere of the brain allows for treatment based on the patient condition or disorder.
Regarding claim 4, Linde discloses the first sensing electrode is positioned at a GPi sensing location to sense the ER to electrostimulation of the STN target (“target area may be one of a subthalamic nucleus” [0210]); and the second sensing electrode is positioned at an STN sensing location to sense the ER to electrostimulation of the GPi target (“target area may be one of an internal globus pallidus” [0210]).
It is well known in the art that the STN and the GPi are connected through nerve pathways in the basal ganglia of the brain. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to sense the ER of the GPi during stimulation of the STN and vice versa in order to achieve the goals of the claimed invention.
Regarding claims 5 and 16, Linde does not disclose an external electrostimulator operatively coupled to one or more cortical electrodes or one or more stereotactic electrodes to modulate one or more of the sensed ER to the electrostimulation at the first neural target or the sensed ER to the electrostimulation at the second neural target, and to produce the desired therapeutic outcome in the patient.
However, Hageman teaches processing circuitry of external programmer issues commands to IMD causing IMD to deliver electrical stimulation therapy via electrodes [0156]. Processing circuitry may cause the stimulation generation circuitry to deliver a second stimulation signal [0037]. Therapeutic benefit from the electrical stimulation used to evoke the evoked signal is possible…electrocorticogram (ECoG) signal is an example of a neurological signal [0058]. It is well understood in the art that an ECoG requires cortical electrodes. Hageman further teaches that delivery of stimulation to one or more regions of brain, such as the subthalamic nucleus (STN), globus pallidus or thalamus, ventralus intermediate (VIM), anterior nucleus (ANT), ventral internal capsule/ventral striatum (VCVS), cortico-basal ganglia-thalamocortical circuit, or anterior insular cortex (AIC), may be an effective treatment to manage disorders, such as Parkinson's disease [0056].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of cortical electrodes of Hagemen with the neuromodulation system of Linde because cortical stimulation has commonly been used to treat pain disorders and other diseases such as Parkinson’s disease.
Regarding claims 8 and 18, Linde does not disclose at least one of the sensed ER to the electrostimulation at the first neural target or the sensed ER to the electrostimulation at the second neural target includes an electrocorticography (ECoG) or a stereoelectroencephalography (sEEG) sensed via one or more cortical electrodes or one or more stereotactic electrodes.
However, Hageman teaches therapeutic benefit from the electrical stimulation used to evoke the evoked signal is possible…electrocorticogram (ECoG) signal is an example of a neurological signal [0058].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of an electrocorticogram of Hageman with the neuromodulation system of Linde because cortical stimulation has commonly been used to treat pain disorders and other diseases such as Parkinson’s disease, and ECoG signals have high clarity and resolution.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Linde in view of Hageman as applied to claim 11 above and further in view of Geva et. al, (US 20190388679 A1, published 12/26/2019, hereinafter known as Geva).
Regarding claim 12 , the modified device of Linde discloses that the controller circuit is configured to determine or adjust the second stimulation setting at the second neural target (“if LD2 detects a biomarker that is below a first threshold and a second threshold, then IMD may decrease a second therapy or turn the second therapy off” [0169] of Linde).
The modified device of Linde does not include step of evaluating the therapeutic outcome includes to compare a spatial distribution of the sensed ER to the electrostimulation at the first neural target to a desired ER spatial distribution, wherein the controller circuit is configured to determine or adjust the second stimulation setting to reduce a discrepancy between the spatial distribution of the sensed ER to the electrostimulation at the second neural target and the desired ER spatial distribution.
However, Geva teaches a method of analyzing performance of a brain stimulation tool in order to determine therapeutic effect and location of stimulating electrode, specifically for electrical treatment with deep brain stimulation (DBS) (Abstract and [0017]). Input to the feature selection algorithm is preferably evaluation scores [0251]. Specific frequency bands (for example, from about 0.5 Hz to about 80 Hz) can also be extracted, optionally and preferably for each electrode…these bands can be plotted as scalp topography maps to provide spatial distribution of the energy [0134]. Controller adjusts the parameters of the treatment of tool responsively to the estimation [0092].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of spatial distribution evaluations of Geva with the modified neuromodulation system of Linde in view of Hageman in order to effectively determine therapeutic parameters and assess therapeutic effect.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Linde in view of Geva.
Regarding claim 20, the device of Linde discloses that the controller circuit is configured to determine or adjust the second stimulation setting at the second neural target (“if LD2 detects a biomarker that is below a first threshold and a second threshold, then IMD may decrease a second therapy or turn the second therapy off” [0169]).
Linde does not disclose evaluating the therapeutic outcome includes to compare a spatial distribution of the sensed ER to the electrostimulation at the first neural target to a desired ER spatial distribution, wherein the controller circuit is configured to determine or adjust the second stimulation setting to reduce a discrepancy between the spatial distribution of the sensed ER to the electrostimulation at the second neural target and the desired ER spatial distribution.
However, Geva teaches a method of analyzing performance of a brain stimulation tool in order to determine therapeutic effect and location of stimulating electrode as discussed above.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of spatial distribution evaluations of Geva with the device and method of Linde in order to effectively determine therapeutic parameters and assess therapeutic effect.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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